Valve leaflet capturing device and system and artificial heart valve system

Abstract

The present invention relates to a valve leaflet capturing device and system and an artificial heart valve system. The valve leaflet capturing device comprises a fishing ring (10), a proximal connecting member (20) and a distal protective member (30), all three being provided with two axially through channels. A control wire (60) is arranged in the channels in a penetrating manner. The control wire (60) can penetrate through the proximal connecting member (20) and extend to the distal end of the fishing ring (10), and after penetrating through the distal protective member (30), the control wire continues to penetrate back towards the proximal end from the other channel. By adjusting the lengths of the control wire (60) on both sides, the distal end direction of the fishing ring (10) is controlled, such that the fishing ring (10) can avoid chordae tendineae in the valve leaflet capturing process and smoothly pass through the outside of the chordae tendineae, thereby capturing all valve leaflets.

Description

Valve leaflet capture device, system and artificial heart valve system Technical Field

[0001] The present invention relates to the field of medical devices for cardiac intervention, and in particular to a valve leaflet capture device, system and artificial heart valve system. Background Art

[0002] Mitral regurgitation is the most common heart valve disease. Although surgical treatment of mitral regurgitation is the primary criterion, these patients may refuse or be judged as unsuitable for traditional open surgery due to high risk.

[0003] In recent years, the successful advancement of aortic valve replacement has stimulated the exploration of transcatheter mitral valve replacement for the treatment of regurgitation. However, mitral valve replacement is much more difficult than aortic valve replacement in many aspects. For example, the spatial structure of the mitral valve is "saddle-shaped" rather than the traditional circular shape. The mitral valve has a more complex tissue structure (valve ring, leaflets, chordae tendineae, papillary muscles). The mitral valve is larger than the aorta and is more slender in shape. The mitral valve leaflets are soft. Compared with aortic valve stenosis or calcification, the mitral valve cannot provide good retention for the replacement valve. At the same time, because the pressure in the left ventricle rises sharply when the left ventricle contracts, if the replacement valve fails to establish adequate anchoring at the mitral valve annulus, there is a risk of displacement. Therefore, effective mitral valve replacement for the treatment of regurgitation must not only withstand the large cyclic loads from the mitral valve, but more importantly, establish a stable and firm anchoring.

[0004] To enhance the radial support provided by the native leaflets to the stent and securely fix the stent to the leaflets, a fishing ring is typically added to the chordae tendineae plexus outside the leaflets. This ring can encircle the leaflets and stent together. However, the fishing ring cannot effectively avoid the chordae tendineae plexus during implantation and thus cannot capture all leaflets. Consequently, after the valve is implanted and anchored with the fishing ring, uneven force can cause chordae tendineae to rupture, leading to paravalvular leakage.

[0005] Based on the above-mentioned deficiencies, how to adjust the angle of the capture ring when delivering it so as to achieve complete capture of the leaflet has become a technical problem that urgently needs to be solved.

[0006] Summary of the Invention

[0007] The present invention discloses a leaflet capturing device, a system and an artificial heart valve system, aiming to solve various problems existing in the prior art.

[0008] The present invention adopts the following technical solutions:

[0009] In one aspect, the present invention provides a leaflet capture device, comprising a capture ring, wherein the capture ring is spirally shaped and can be coiled around the annulus of the mitral valve / tricuspid valve and position an artificial heart valve implanted in the mitral valve / tricuspid valve;

[0010] The cross-sectional structure of the fishing ring includes a core body, a first wrapping layer and a second wrapping layer from the inside to the outside;

[0011] The core is made of preformed memory metal, which can undergo elastic deformation in at least radial and axial directions to adapt to changes in the shape of myocardial tissue;

[0012] The first wrapping layer is provided with a first adjustment channel and a second adjustment channel, both of which axially penetrate the first wrapping layer and are respectively arranged on both sides of the circumference of the core body. The first adjustment channel and the second adjustment channel are used for passing the control wire.

[0013] As an optimal technical solution, it also includes a proximal connecting piece and a distal protective piece; the proximal connecting piece is provided with a first adjustment through hole and a second adjustment through hole which are respectively connected to the first adjustment channel and the second adjustment channel, and the first adjustment through hole and the second adjustment through hole are used to pass the control wire.

[0014] As a preferred technical solution, a connecting hole is further provided in the middle of the proximal connecting piece, and the connecting hole is used for releasable connection with the pushing device.

[0015] As a preferred technical solution, the core body includes nickel-titanium alloy, the first wrapping layer includes ePTFE or PTFE, and the second wrapping layer includes PET.

[0016] In a second aspect, the present invention provides a leaflet capture system, comprising the leaflet capture device described above, and a pushing device, the pushing device comprising:

[0017] operating handle;

[0018] A push wire is axially inserted into the operating handle, and an external thread is provided at the distal end of the push wire, which can be threadedly connected to the proximal connector;

[0019] A pushing catheter, wherein the pushing wire is passed through the pushing catheter;

[0020] A control wire fixing assembly, comprising a first control wire fixing member and a second control wire fixing member, both of which are threadedly connected to the proximal end of the operating handle;

[0021] The control wire is looped and passed through the leaflet capturing device and the pushing device, and the two ends of the control wire are respectively arranged at the proximal ends of the first control wire fixing component and the second control wire fixing component.

[0022] As a preferred technical solution, the push catheter is configured as a three-lumen tube, the lumen in the middle of the push catheter is used for passing the push wire, and the lumens on both sides of the push catheter are used for passing the control wire.

[0023] As a preferred technical solution, a catheter cavity and two guide cavities are provided in the operating handle. The catheter cavity is used to fix the push catheter, and the two guide cavities are roughly spindle-shaped and are used for positioning and guiding the control wire.

[0024] As a preferred technical solution, it also includes a push wire fixing piece, which is threadedly connected to the proximal end of the operating handle, and the proximal end of the push wire is axially passed through and fixed in the push wire fixing piece.

[0025] As a preferred technical solution, the control wire fixing assembly also includes a first sub-control wire fixing member and a second sub-control wire fixing member, which are respectively arranged at the proximal ends of the first control wire fixing member and the second control wire fixing member. Compression springs are arranged between the first sub-control wire fixing member and the first control wire fixing member, and between the second sub-control wire fixing member and the second control wire fixing member. The two ends of the control wire are respectively arranged at the proximal ends of the two compression springs, and the compression springs are used to provide pre-tightening force for the control wire.

[0026] As a preferred technical solution, the first sub-control wire fixing member and the second sub-control wire fixing member are respectively provided with an axially slidable pre-tightening connector, and the two ends of the control wire are respectively connected to the two pre-tightening connectors. The pre-tightening connectors are tightened by compression springs, and the compression springs can provide pre-tightening force for the control wire through the pre-tightening connectors.

[0027] In a third aspect, the present invention provides an artificial heart valve system, comprising the above-mentioned leaflet capture device, and an artificial heart valve;

[0028] At least a portion of the artificial heart valve defines a flow channel for blood circulation. The artificial heart valve can be positioned inside the native valve and replace the physiological function of the native valve.

[0029] At least a portion of the prosthetic heart valve cooperates with the leaflet capture device.

[0030] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0031] On the one hand, the present invention provides a leaflet capture device, which includes a capture ring, a proximal connector and a distal protective member. All three have two axially through channels, through which a control wire can be passed. The control wire can pass through the proximal connector and extend to the distal end of the capture ring. After passing through the distal protective member, it continues to pass back to the proximal end through another channel. By adjusting the length of the control wires on both sides, the distal direction of the capture ring can be controlled, so that the capture ring can avoid the chordal plexus during the leaflet capture process and pass smoothly from the outside of the chordal plexus, thereby capturing all leaflets.

[0032] Furthermore, the present invention also provides a pushing device that can be connected to the leaflet capture device. The pushing wire of the pushing device can be releasably connected to the proximal connector of the leaflet capture device, and the control wire can pass through the proximal end of the operating handle of the pushing device to achieve length adjustment of the control wires on both sides.

[0033] On the other hand, the present invention also provides an artificial valve system, including a valve stent and the above-mentioned leaflet capture device, wherein the leaflet capture device can surround the outside of the valve chordae tendineae, capturing the native leaflets while providing a positioning point for the subsequent implantation of the valve stent; the valve stent can be implanted in the mitral valve and tricuspid valve, and replace the physiological function of the native valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0035] FIG1 is a schematic structural diagram of a fishing ring in a preferred embodiment disclosed in Example 1 of the present invention;

[0036] FIG2 is a cross-sectional view of a fishing ring according to a preferred embodiment of the present invention disclosed in Example 1;

[0037] FIG3 is a schematic structural diagram of a leaflet capturing device in another preferred embodiment disclosed in Example 1 of the present invention;

[0038] FIG4 is a connection diagram of a proximal connector in a preferred embodiment disclosed in Example 1 of the present invention;

[0039] FIG5 is a schematic structural diagram of a pushing device in a preferred embodiment disclosed in Example 2 of the present invention;

[0040] FIG6 is an exploded view of the structure of a pushing device in a preferred embodiment disclosed in Example 2 of the present invention;

[0041] FIG7 is a cross-sectional view of a pushing device according to a preferred embodiment of the present invention disclosed in Example 2;

[0042] FIG8 is a schematic structural diagram of an operating handle in a preferred embodiment disclosed in Example 2 of the present invention;

[0043] FIG9 is a schematic structural diagram of a first sub-control wire fixing member and a second sub-control wire fixing member in a preferred embodiment disclosed in Example 2 of the present invention;

[0044] FIG10 is a diagram showing a leaflet capture device in use during systole in a preferred embodiment of Example 2 of the present invention;

[0045] FIG11 is a diagram showing the leaflet capture device in use during diastole in a preferred embodiment disclosed in Example 2 of the present invention.

[0046] Explanation of the accompanying drawings: Fishing ring 10, core body 11, first wrapping layer 12, first adjustment channel 121, second adjustment channel 122, second wrapping layer 13, proximal connector 20, first adjustment through hole 21, second adjustment through hole 22, connecting hole 23, distal protection part 30, operating handle 40, push wire fixing part 41, first control wire fixing part 42, first sub-control wire fixing part 43, compression spring 44, second control wire fixing part 45, second sub-control wire fixing part 46, catheter cavity 47, guide cavity 48, pre-tightening connector 49, push wire 50, push catheter 51, control wire 60, leaflet 70, tendon 80. DETAILED DESCRIPTION

[0047] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0048] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or a magnetic connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. In addition, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0049] In the field of interventional medical device technology, the direction closest to the operator is generally defined as the proximal end, and the direction away from the operator is defined as the distal end. The direction of the central axis of objects such as cylinders and tubes is defined as the axial direction. The radial direction refers to the direction passing through the central axis in a radial plane, for example, along a straight line of diameter or radius, or perpendicular to the central axis.

[0050] As described in this article, "spiral" means that the structure of the capture ring is similar to a spiral spring, but because it contains multiple functional segments, it is not an absolute / standard spiral; "coiled outside the mitral valve or tricuspid valve annulus" means that the capture ring can match the shape of the mitral valve / tricuspid valve annulus to enhance its stability, rather than its shape completely matching the shape of the native mitral valve / tricuspid valve annulus.

[0051] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0052] Example 1

[0053] In order to solve the problems existing in the prior art, this embodiment provides a leaflet capture device, which needs to be used together with an artificial heart valve. The two work together to achieve transcatheter mitral valve or tricuspid valve replacement.

[0054] 1-4 , the leaflet capture device includes, from proximal to distal end, a proximal connector 20, a capture ring 10, and a distal protective member 30, wherein the proximal connector 20 is used to achieve a releasable connection with the pushing device, and the distal protective member 30 is used to protect the myocardial tissue during the pushing process of the leaflet capture device. The capture ring 10 can be coiled around the outside of the mitral valve or tricuspid valve annulus in a roughly spiral shape to position the artificial heart valve implanted in the annulus. Preferably, a plurality of developing rings are also provided on the capture ring 10 to determine the position of the leaflet capture device in the body under an imaging system.

[0055] As shown in Figure 2, in a preferred embodiment, the cross-sectional structure of the capture ring 10 includes a core body 11, a first wrapping layer 12 and a second wrapping layer 13 from the inside to the outside, wherein the core body 11 is made of preformed memory metal, which can bend according to the blood vessels during transportation, and return to the preformed shape after release, and can undergo radial and axial elastic deformation to adapt to changes in the shape of the myocardial tissue; the first wrapping layer 12 has a certain elasticity and buffering capacity, and can deform together with the core body 11; the second wrapping layer 13 has a certain friction force to reduce the risk of displacement of the capture ring 10 during the cardiac cycle.

[0056] Preferably, taking the mitral valve as an example, the core body 11 is roughly spiral after being released at the annulus of the mitral valve, while providing axial and radial forces to cooperate with the artificial heart valve implanted in the mitral valve and interact with it. The cooperation between the two can reduce the size of the natural mitral valve and reduce the mitral regurgitation of the natural valve leaflets. At the same time, the capture ring 10 can anchor the position of the artificial heart valve more firmly, effectively preventing it from unexpected displacement.

[0057] In a preferred embodiment, since the core 11 does not directly contact the myocardial tissue, it is not necessary to select a biocompatible material. Specifically, memory alloys, polymers, fibers or other high molecular materials can be selected. Preferably, the core 11 is formed by heat-setting a memory alloy, more preferably a nickel-titanium alloy.

[0058] Preferably, the first wrapping layer 12 is made of a smooth and dense polymer material.

[0059] In a preferred embodiment, the first wrapping layer 12 is made of PTFE, which has good chemical stability and heat resistance, as well as a low friction coefficient, excellent corrosion resistance and high aging resistance. In addition, PTFE also has good tensile strength and stiffness so that it can deform along with the core 11.

[0060] In another preferred embodiment, the first wrapping layer 12 is made of ePTFE, which is a modified material of PTFE. It is formed into a microporous structure through expansion and stretching on the basis of PTFE. On the one hand, the microporous structure can make the first wrapping layer 12 lighter and will not add too much burden after implantation in the heart. On the other hand, the microporous structure can induce myocardial tissue to grow inward, so as to further strengthen the coordination between the capture ring 10 and the mitral valve.

[0061] Preferably, the second wrapping layer 13 is made of PET film. Since it has the characteristics of high tensile strength, thin thickness, high friction coefficient, and high surface tension, it can increase the stability of the position of the fishing ring 10 after the leaflet 70 captures it.

[0062] In a preferred embodiment, the first wrapping layer 12 is provided with a first adjustment channel 121 and a second adjustment channel 122, both of which axially penetrate the first wrapping layer 12 and are respectively arranged on the left and right sides of the circumference of the core body 11, and the first adjustment channel 121 and the second adjustment channel 122 are used to pass the control wire 60.

[0063] Preferably, the inner diameters of the first regulating channel 121 and the second regulating channel 122 are consistent, and the inner diameter size is larger than the diameter of the control line. The inner diameter sizes of the two channels are not specifically limited here.

[0064] Preferably, the center positions of the first adjustment channel 121 and the second adjustment channel 122 are on the same diameter line of the first wrapping layer 12; more preferably, the distal section of the fishing ring 10 spirally extends toward the ventricular side, and the aforementioned diameter line and the plane in which the distal end of the fishing ring 10 is located are roughly parallel. At this time, when the control wires 60 on both sides are pulled, the distal end of the fishing ring 10 can move radially inward or outward within the plane of its bending extension.

[0065] It should be noted that the control wire 60 can first pass through the proximal end of the first adjustment channel 121, pass out from the distal end, then pass back through the second adjustment channel 122, and finally pass out from the proximal end of the second adjustment channel 122. Alternatively, the control wire 60 can first pass through the proximal end of the second adjustment channel 122, pass out from the distal end, then pass back through the first adjustment channel 121, and finally pass out from the proximal end of the first adjustment channel 121. The first adjustment channel 121 and the second adjustment channel 122 are used for naming purposes only and are not distinguished in order or left and right. The two have the same function.

[0066] In an optional embodiment, the first adjustment channel 121 and the second adjustment channel 122 can be provided as a pair, with the first adjustment channel 121 being provided on one side of the first wrapping layer 12, adjacent to each other, and the second adjustment channel 122 being provided on the opposite side of the first wrapping layer 12, also adjacent to each other. In this case, two control wires 60 are provided, one control wire 60 being looped through the pair of first adjustment channels 121, and the other control wire 60 being looped through the pair of second adjustment channels 122. In this case, by controlling the two control wires 60 separately, the distal end of the fishing ring 10 can be adjusted in a curved manner.

[0067] Preferably, the control wire 60 is made of a high-tensile-strength material that is not easily broken when pulled, and can be selected from ultra-high molecular weight polyethylene thread, aramid thread, nylon thread, polyester thread, etc. When the capture ring 10 is implanted outside the valve leaflets 70, the bending direction of the distal end of the capture ring 10 can be controlled by adjusting the length of the left and right control wires 60 in vitro. The distal end of the capture ring 10 bends toward the side where the control wire 60 is pulled, thereby avoiding the chordal plexus and achieving capture of all valve leaflets 70.

[0068] Preferably, the distal protection member 30 is hemispherical and fixed to the distal end of the fishing ring 10. The material thereof can be any biocompatible metal or a polymer material with developing properties, and the same material as the developing ring can be selected.

[0069] As shown in Figures 3 and 4, preferably, the proximal connecting member 20 is fixed to the proximal end of the fishing ring 10, and the proximal connecting member 20 includes a connecting hole 23, a first adjustment hole 21 and a second adjustment hole 22, the centers of which are located on the same diameter line of the proximal connecting member 20.

[0070] Preferably, the connection hole 23 is provided with an internal thread for releasable connection with the pushing device.

[0071] Preferably, the first adjustment through hole 21 is connected to the first adjustment channel 121, and the second adjustment through hole 22 is connected to the second adjustment channel 122. The control wire 60 first passes through the first adjustment through hole 21 and the first adjustment channel 121 until the distal end of the capture ring 10 and then passes back through the second adjustment channel 122 and the second adjustment through hole 22. Both ends of the control wire 60 are located on the pushing device outside the body, and the pushing of the leaflet capture device and the bending and turning of the distal end are achieved by operating the pushing device.

[0072] In an optional embodiment, when the first adjustment channel 121 and the second adjustment channel 122 are both set as a pair, the first adjustment through hole 21 and the second adjustment through hole 22 are also set as a pair and match the positions of the first adjustment channel 121 and the second adjustment channel 122.

[0073] Example 2

[0074] In this embodiment, a leaflet capture system is provided, which includes the leaflet capture device in the above-mentioned embodiment 1, and also includes a pushing device that can be releasably connected thereto. The technical features already included in the above-mentioned embodiment 1 are naturally inherited in this embodiment and will not be repeated.

[0075] As shown in Figure 2-11, the pushing device includes an operating handle 40, a pushing wire 50, a pushing catheter 51, a control wire 60 and a control wire fixing assembly, wherein the control wire 60 and the pushing catheter 51 are both arranged in multiple cavities of the pushing catheter 51, and the distal end of the pushing wire 50 can be releasably connected to the leaflet capture device to achieve the pushing of the leaflet capture device in the human body. The control wire fixing assembly can fix the two ends of the control wire 60 and adjust the length of the control wire 60 on both sides to achieve control of the distal direction of the capture ring 10.

[0076] Preferably, a catheter cavity 47 is provided at the distal end of the operating handle 40 , and the catheter cavity 47 is used to fix the push catheter 51 . A guide cavity 48 is provided inside the operating handle 40 , and the guide cavity 48 is roughly spindle-shaped and is used to position and guide the control wire 60 .

[0077] As shown in FIG8 , in a preferred embodiment, the outer shell of the operating handle 40 includes an upper shell and a lower shell, which are connected and fixed. Specifically, the connection method may be bonding or snapping, which is not specifically limited here.

[0078] As shown in FIG6 and FIG7 , in a preferred embodiment, the guide cavity includes two shuttle tubes fixed in the operating handle 40 to prevent the control wire 60 from accidentally sliding into the gap at the connection between the upper shell and the outer shell.

[0079] Preferably, the push catheter 51 is configured as a three-lumen tube, the centers of the three lumens are located on the same diameter line of the push catheter 51, the lumen in the middle of the push catheter 51 is used for passing the push wire 50, and the lumens on both sides of the push catheter 51 are used for passing the control wire 60.

[0080] In an optional embodiment, when the first adjustment channel 121 and the second adjustment channel 122 are both set as a pair, there are two control wires 60. At this time, the number and layout of the lumens in the push catheter 51 should match the control wires 60, forming a five-lumen tube.

[0081] Preferably, the push wire 50 is made of a material with flexibility, conductivity and high strength, preferably nickel titanium wire.

[0082] The distal end of the pushing wire 50 is provided with an external thread, which is used to be spirally connected to the proximal connector 20 of the leaflet capture device. The proximal end of the pushing wire 50 is fixed on the pushing wire fixing part 41, and the pushing wire fixing part 41 is threadedly connected to the proximal end of the operating handle 40. By rotating the pushing wire fixing part 41, the distal end of the pushing wire 50 and the proximal end of the leaflet capture device can be released. After unscrewing the pushing wire fixing part 41 from the operating handle 40, the pushing wire 50 can be driven to withdraw from the body.

[0083] As shown in Figure 9, preferably, the control wire fixing assembly includes a first control wire fixing member 42, a first sub-control wire fixing member 43, a second control wire fixing member 45, a second sub-control wire fixing member 46, a pair of compression springs 44 and a pair of pre-tightening connectors 49. The first control wire fixing member 42 and the second control wire fixing member 45 are both provided with a channel for the control wire 60 to pass through.

[0084] In a preferred embodiment, the first control wire fixing member 42 is fixedly connected to or integrally formed with the first sub-control wire fixing member 43, and a compression spring 44 is arranged between the first sub-control wire fixing member 43 and the first control wire fixing member 42; the second control wire fixing member 45 is fixedly connected to or integrally formed with the second sub-control wire fixing member 46, and another compression spring 44 is arranged between the second sub-control wire fixing member 46 and the second control wire fixing member 45; the two ends of the control wire 60 are defined as the first end and the second end, wherein the first end of the control wire 60 passes through the first control wire fixing member 42 and is connected to the proximal end of the compression spring 44 in the first sub-control wire fixing member 43, and the second end of the control wire 60 passes through the first control wire fixing member 42 and is connected to the proximal end of the compression spring 44 in the second sub-control wire fixing member 46.

[0085] In another preferred embodiment, an axially slidable pre-tightening connector 49 is provided in the first sub-control wire fixing member 43, and another pre-tightening connector 49 is provided in the second sub-control wire fixing member 46. The two ends of the control wire 60 are respectively connected to the two pre-tightening connectors 49, and each pre-tightening connector 49 is tightened by the compression spring 44.

[0086] Preferably, the first control wire fixing member 42 and the second control wire fixing member 45 are both threadedly connected to the proximal end of the operating handle 40. By rotating one of the two, the length of the control wire 60 on one side can be tightened and shortened, thereby realizing the steering of the distal end of the fishing ring 10; under the action of the pressing force of the compression spring 44, the control wire 60 on the untightened side is still pressed toward the proximal end by the compression spring 44, so that the control wire 60 on the untightened side can still remain in a tightened state. Due to the existence of the pre-tightening force, the adjustment of the distal end of the fishing ring 10 can be avoided from being affected by the relaxation of the control wire 60.

[0087] Specifically, when the pushing device and the leaflet capture device are assembled, the first end of the control wire 60 is arranged at the proximal end of the first sub-control wire fixing component 43 and is tightened by the compression spring 44 therein, and the second end passes through the operating handle 40, the pushing catheter 51, the first adjustment through hole 21, the first adjustment channel 121, the second adjustment through hole 122, the second adjustment through hole 22, the pushing catheter 51 and the operating handle 40 in sequence, and is arranged at the proximal end of the second sub-control wire fixing component 46, and is tightened by the compression spring 44 in the second sub-control wire fixing component 46.

[0088] In an optional embodiment, when the first adjustment channel 121 and the second adjustment channel 122 are both set as a pair, there are two control wires 60. At this time, the control wire fixing assembly should be set as two sets, and the structure of each set of control wire fixing assembly is the same as the above embodiment.

[0089] In this embodiment, the specific operation method of the above leaflet capture system is as follows:

[0090] When the leaflet capture device is implanted in the body, and encounters the diastole and contraction of the heart, the leaflet 70 moves continuously under the traction of the tendon 80. In the contracted state, the leaflet 70 is closed, and the tendon 80 moves toward the middle, as shown in Figure 10. The capture ring 10 can easily pass through the outside of the tendon 80 to capture the leaflet 70. However, when the heart is in diastole, the leaflet 70 opens, and the tendon 80 expands to both sides, as shown in Figure 11. At this time, the capture ring 10 cannot easily pass through the outside of the tendon 80 and cannot capture the leaflet 70. In this case, the first control wire fixing part 42 (or the second control wire fixing part 45) on the rotating pushing device can be operated. ), so that the side control wire 60 is tightened to control the movement of the distal end of the fishing ring 10 toward the rear, while ensuring that the second control wire fixing piece 45 (or the first control wire fixing piece 42) does not move, thereby tightening the control wire 60 on one side, driving the fishing ring 10 to expand outward, and ensuring that the fishing ring 10 can completely capture the leaflet 70. After the fishing ring 10 is implanted, the control wire 60 is cut off at the first control wire fixing piece 42 or the second control wire fixing piece 45, and then pulled out from the other end. By rotating the pushing wire fixing piece 41, the pushing wire 50 and the fishing ring 10 are released, and then the pushing device is withdrawn from the body.

[0091] Example 3

[0092] This embodiment 3 provides an artificial valve system. This embodiment, based on the structure of the leaflet capture device disclosed in embodiment 1, also includes an artificial heart valve. The artificial heart valve can be positioned inside the native valve to replace the physiological function of the native valve. The technical features already included in embodiment 1 or embodiment 2 are naturally inherited in this embodiment.

[0093] Preferably, the artificial heart valve is configured to be able to expand at the native mitral valve to eliminate mitral valve regurgitation; the main body of the artificial heart valve defines a flow channel for blood circulation, and the main body can cooperate with the capture ring 10.

[0094] Preferably, the structure of the artificial heart valve includes a valve stent, a sealing membrane and an artificial valve leaflet. The structures of the three can refer to any embodiment disclosed in the prior art and are not specifically limited here.

[0095] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. A leaflet capture device, comprising a capture ring, characterized in that: The fishing ring is spiral-shaped and can be coiled around the valve ring of the mitral valve / tricuspid valve and position the artificial heart valve implanted in the mitral valve / tricuspid valve; The cross-sectional structure of the fishing ring includes a core body, a first wrapping layer and a second wrapping layer from the inside to the outside; The core is made of preformed memory metal, which can be elastically deformed at least in radial and axial directions to adapt to changes in the shape of myocardial tissue; The first wrapping layer is provided with a first adjustment channel and a second adjustment channel, both of which axially penetrate the first wrapping layer and are respectively arranged on both sides of the circumference of the core body, and the first adjustment channel and the second adjustment channel are used for passing the control wire.

2. The leaflet capture device according to claim 1, characterized in that: It also includes a proximal connecting piece and a distal protecting piece; the proximal connecting piece is provided with a first adjusting through hole and a second adjusting through hole which are respectively connected with the first adjusting channel and the second adjusting channel, and the first adjusting through hole and the second adjusting through hole are used for passing the control wire.

3. The leaflet capture device according to claim 2, characterized in that: A connecting hole is also provided in the middle of the proximal connecting piece, and the connecting hole is used for releasably connecting with the pushing device.

4. The leaflet capture device according to claim 3, characterized in that: The core body comprises nickel-titanium alloy, the first wrapping layer comprises ePTFE or PTFE, and the second wrapping layer comprises PET.

5. A leaflet capture system, characterized in that: The device comprises a leaflet capture device as claimed in claim 4, further comprising a pushing device, wherein the pushing device comprises: Operating handle; A push wire, the push wire is axially inserted into the operating handle, the distal end of the push wire is provided with an external thread, and the push wire can be threadedly connected to the proximal connecting piece; A pushing catheter, wherein the pushing wire is inserted into the pushing catheter; A control wire fixing assembly, the control wire fixing assembly comprising a first control wire fixing member and a second control wire fixing member, both of which are threadedly connected to the proximal end of the operating handle; A control wire is looped and passed through the leaflet capturing device and the pushing device, and two ends of the control wire are respectively arranged at the proximal ends of the first control wire fixing member and the second control wire fixing member.

6. The leaflet capture system according to claim 5, characterized in that: The push catheter is configured as a three-lumen tube, the lumen in the middle of the push catheter is used for passing the push wire, and the lumens on both sides of the push catheter are used for passing the control wire.

7. The leaflet capture system according to claim 5, characterized in that: The operating handle is provided with a catheter cavity and two guide cavities. The catheter cavity is used to fix the push catheter. The two guide cavities are roughly shuttle-shaped and are used to position and guide the control wire.

8. The leaflet capture system according to claim 5, characterized in that: It also includes a push wire fixing piece, which is threadedly connected to the proximal end of the operating handle, and the proximal end of the push wire is axially penetrated and fixed in the push wire fixing piece.

9. The leaflet capture system according to claim 5, characterized in that: The control wire fixing assembly also includes a first sub-control wire fixing member and a second sub-control wire fixing member, which are respectively arranged at the proximal ends of the first control wire fixing member and the second control wire fixing member. Compression springs are arranged between the first sub-control wire fixing member and the first control wire fixing member, and between the second sub-control wire fixing member and the second control wire fixing member. The two ends of the control wire are respectively arranged at the proximal ends of the two compression springs, and the compression springs are used to provide pre-tightening force for the control wire.

10. The leaflet capture system according to claim 9, characterized in that: The first sub-control wire fixing member and the second sub-control wire fixing member are respectively provided with an axially slidable pre-tightening connector, and the two ends of the control wire are respectively connected to the two pre-tightening connectors, and the pre-tightening connectors are tightened by the compression spring, and the compression spring can provide a pre-tightening force for the control wire through the pre-tightening connector.

11. An artificial heart valve system, characterized in that: The leaflet capture device of claim 4 further comprising an artificial heart valve; At least a portion of the artificial heart valve defines a flow channel for blood circulation, and the artificial heart valve can be positioned inside the native valve and replace the physiological function of the native valve; At least a portion of the artificial heart valve cooperates with the leaflet capture device.

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